Acta Dermato-Venereologica issue 50:1 98-1CompleteContent | Page 14

38 INVESTIGATIVE REPORT Validation of Pruritus Measures Gathered with the Electronic Patient-reported Outcome System MoPat Michael STORCK 1 , Claudia ZEIDLER 2 , Mirjam REHR 1 , Claudia RIEPE 2 , Martin DUGAS 1 , Sonja STÄNDER 2 and Iñaki SOTO-REY 1 Institute of Medical Informatics, University of Münster, and 2 Center for Chronic Pruritus, University Hospital Münster, Münster, Germany 1 In order to improve diagnosis and treatment, physi- cians require information about the social context and quality of life of their patients. The Center for Chronic Pruritus at the University Hospital Münster achieves this goal using the electronic patient-reported out- come system “Mobile Patient Survey”, which assesses pruritus and quality of life measures. The aim of this study is to evaluate the consistency and reliability of such measures. A total of 42 patients, age range 19–82 years, participated in the study and were asked to as- sess the measures at baseline via a paper question- naire, and to use the “Mobile Patient Survey” at base- line and after 1 h in order to test reliability. Statistical analysis was performed using coefficient r c for metric variables and weighted kappa κ w for categorical vari- ables. The internal consistency of all measures was un- affected. It was shown that 6 out of 7 measures can be assessed without loss of reliability. It is recommended that questionnaires for electronic usage are assessed for validity and reliability. Key words: validation; patient-reported outcome measures; pruritus. Accepted Sep 19, 2017; Epub ahead of print Sep 20, 2017 Acta Derm Venereol 2018; 98: 38–43. Corr: Michael Storck, Institute of Medical Informatics, University of Müns- ter, Domagkstraße 9, DE-48149 Münster, Germany. E-mail: michael. [email protected] I n order to provide the best healthcare treatment, physicians require knowledge not only of a patient’s clinical history, but also of their corresponding social context and quality of life. With increasing workload, the time clinicians can spend with their patients, and thus the possibility to collect this information, is decreasing (1). Patient data reported by the patient without interpreta- tion of the patient’s response by a clinician, so called “patient-reported outcomes” (PRO) (2), can be helpful for better understanding of the patient’s social context and his/her perception of the illness, which enhances patient diagnosis and treatment. Patient-based data is usually gathered via paper and pencil (P&P) questionnaires. Electronic collection of PROs offers several advantages compared with P&P: reduction in errors produced by typewriting; reduction in missing data by requiring completion; and reduction in invalid data through implementation of skip patterns, among others (3). In order to overcome the drawbacks doi: 10.2340/00015555-2799 Acta Derm Venereol 2018; 98: 38–43 of P&P questionnaires, some projects use an electronic PRO (ePRO) sy stem allowing the patient to answer a digital survey (4). At the University Hospital Münster (UKM), such a system, called the “Mobile Patient Survey (MoPat)”, was implemented prototypically in 2010 and re-implemented in 2014 (5). MoPat is a web-based sur- vey system that allows patients to complete multilingual digital questionnaires. The results are automatically sent to the electronic health record and/or research database. The first department to use MoPat in routine care was the Center for Chronic Pruritus (CCP) of the UKM (6). To date, several PRO measures have been collected with MoPat, including: visual analogue scale (VAS) (7); nu- merical rating scale (NRS) (7); verbal rating scale (VRS) (7); dynamic pruritus score (DPS) (8); Dermatology Life Quality Index (DLQI) (9); Hospital Anxiety and Depression Scale (HADS) (10); and ItchyQoL (German version) (11). All of these PROs have been validated as P&P tools. Due to the importance of assessment validity and re- liability, the corresponding electronic version of these tools should also be validated. We assume that aspects of validity other than reliability are mostly unaffected by the mode of assessment (P&P vs. ePRO). Therefore, the relevant aspect of validity when switching from P&P to ePRO is reliability, and by confirming reliability and internal consistency, validity is also confirmed. The aim of this study is to evaluate the internal consistency and reliability of the electronic versions of the above- mentioned assessment tools implemented within MoPat. METHODS During the 12-month period to October 2015, 42 subjects (20 males and 22 females) aged ≥ 18 years with chronic pruritus (CP) of an intensity of at least 2 points on the NRS (mean over 24 h) were recruited in the CCP to participate in the study. The patients’ ages range from 19 to 82 years, median age 58 years. Other demographic data including diagnosis and cause of itch, presented according to the International Forum for the Study of Itch (12) are shown in Fig. 1. The aforementioned PROs were implemented within MoPat. The participants were asked to complete the P&P version of the questionnaires and the MoPat version on an Apple iPad at baseline. After 1 h, the participants then re-answered the PROs using the MoPat. The data from the P&P PROs was typewritten and com- bined with the MoPat export in an Excel file for data cleaning. Statistical analysis was conducted with R (13) (version 3.3.3), using RStudio (version 1.0.136). All subjects provided written informed consent for data collection and analysis. The ethics com- mittee of the University of Münster approved the trial (number This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2018 Acta Dermato-Venereologica.